Kornimate/medical-research-clean huggingface dataset:
molecular mediators of physical exercise and carnosine induced effects in patients with preclinical and early stage neurodegenerative disease

Conditions: Subjective Cognitive Impairment; Mild Cognitive Impairment; Parkinson Disease; Healthy Volunteers

Summary: the purpose of this study is to investigate the beneficial effects of regular exercise and the impact of food supplement carnosine on cognitive, motoric and metabolic functions as well as on specific biologically active substances in volunteers with subjective (sci) or mild (mci) cognitive impairment, as well as in patients in early stages of parkinson's disease. the investigators assume the immediate intervention-associated health benefit for volunteers.

standard operating procedures for patient recruitment, data collection, data management, data analysis routinely used in biomedical research center, slovak academy of sciences, university hospital bratislava and comenius university, bratislava will be employed. gait and balance parameters will be examined and analysed at the department of behavioural neuroscience, centre of experimental medicine, slovak academy of sciences, bratislava, slovakia statistical analysis will be employed to address the primary and secondary objectives, as specified in the study protocol.

Eligibility criteria:
inclusion criteria: * signed informed consent * age 55 - 80 years * presence of subjective cognitive impairment (sci), mild cognitive impairment (mci) or early stage of parkinson's disease (hoehn-yahr 1st-2nd stage), assessed by experienced neurologist exclusion criteria: * serious systemic cardiovascular, hepatic, renal disease, cancer * lack of compliance

Keywords: parkinson's disease exercise training motor functions cognitive functions
sapropterin as a treatment for autistic disorder

Conditions: Autistic Disorder

Summary: this study is intended to provide a definitive test of the hypothesis that elevating sapropterin (tetrahydrobiopterin, a cofactor for several key brain enzymes)concentrations in the cns will result in measurable improvements in core symptoms of autism in young individuals, under age 6 years. the study will entail a double-blind, placebo-controlled 16-week intervention.

over the past 20 years, several studies have suggested that sapropterin (tetrahydrobiopterin) might ameliorate core symptoms of autism at least in young (under age 6) subjects. however, those studies had somewhat questionable methodologies, a major one being that the doses of sapropterin used were roughly one tenth that thought to be needed to provide physiologically meaningful increases of sapropterin in the central nervous system (cns). this study will look at the impact of a sustained exposure to this higher dose in well-diagnosed young children with autism.

Eligibility criteria:
inclusion criteria: * parents sign informed consent * child meets criteria for autistic disorder (based on score on the autism diagnostic interview-revised (adi-r) and the autism diagnostic observation schedule (ados), given by a certified administrator, research reliable) * child has a developmental quotient (dq) ≥ 50 (vineland adaptive scales, interview edition) * parents agree to delay initiation of other treatments during double-blind trial exclusion criteria: * child has had seizures in past 6 months or a change in seizure medications in past 4 weeks. * child has \> 18 points on subscale of (autism behavior checklist) abc-i * child is taking any psychoactive medication other than supplements, anticonvulsants, or soporifics (melatonin, diphenhydramine) * child has had any change in standing medications in the past 4 weeks. * child has known genetic disorders * child has known severe neurological disorders, including cerebral palsy

Keywords: autism
thulium fiber laser enucleation of the prostate (thuflep): efficacy and safety

Conditions: Prostatic Hyperplasia

Summary: the aim of our study is to estimate the efficacy, safety and postoperative complications of the thulium fiber laser enucleation of the prostate (thuflep) with urolase system (nto ire-polus, russia).

in all patients, ipss, qmax, qol, prostate volume, and iief-5 are measured prior to surgery. for thuflep, we use the urolase system (nto ire-polus, russia) and a 600 mcm fiber. the thulium fiber laser is set with a mean output power of 60 w and energy of 1.5 j. tissue morcellation is completed with the piranha morcellator (richard wolf, germany). at the end of the procedure a 22 french three-way foley catheter is placed. ipss, qmax, qol, prostate volume are recorded at 1, 3 and 6 months after surgery. iief-5 are recorded at 3 and 6 months after surgery.

Eligibility criteria:
inclusion criteria: * men aged 18 or older * infravesical obstruction due to prostatic hyperplasia (ipss \> 20 or qmax \<10) exclusion criteria: * participation in another clinical study * prostate cancer (pathology confirmed) * urinary tract infection * neurogenic bladder

Keywords: prostate bph laser endoscopic enucleation of the prostate thulium thulium fiber laser
metabolic acidosis and vascular function in patients with chronic kidney disease

Conditions: Metabolic Acidosis; Chronic Kidney Disease

Summary: cardiovascular disease (cvd) is the leading cause of death in patients with chronic kidney disease (ckd) and large artery damage is a major factor that contributes to death. metabolic acidosis is a common complication of ckd resulting from an inability of the diseased kidney to excrete the daily dietary acid load and it is associated with all-cause mortality in patients with ckd. however, the effect of treatment of metabolic acidosis with oral sodium bicarbonate on endothelial dysfunction and arterial stiffness in patients with ckd has not been evaluated. the investigators propose a prospective, randomized, controlled, open-label 14-week crossover pilot study examining the effect of treatment of metabolic acidosis with oral sodium bicarbonate on vascular endothelial function in 20 patients with ckd stage iv with metabolic acidosis.


Eligibility criteria:
inclusion criteria * age 40-70 years * ckd stage iv (egfr 15-29 ml/min/1.73m2; stable renal function in the past 3 months) * serum bicarbonate level of \< 20 and ≥ 16 meq/l (at least 2 consecutive weekly measurements) * body mass index \< 40 kg/m2 (fmd measurements can be inaccurate in severely obese patients) * ability to give informed consent * stable anti-hypertensive, diabetic and lipid lowering regimen for at least one month prior to randomization exclusion criteria: * significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year * uncontrolled hypertension * expected to undergo living related kidney transplant in next 6 months * expected to start dialysis in next 3 months * overt congestive heart failure * use of sevelamer * use of calcium carbonate

Keywords: vascular endothelial cells
implementation of anal cancer screening and treatment in nigeria

Conditions: Education, Medical

Summary: the study is a feasibility pilot trial testing 2 types of training protocols on a single physician. the first training protocol is the current standard and was developed in high-income settings. the second training protocol will be developed so tailored to the nigerian setting. investigators will test if the physician performs differently in their ability to conduct anal cancer screening and treatment between the 2 training protocols.

in aim 1, anal cancer screening and treatment based on standard training protocols of how to screen and treat high-grade intraepithelial lesions (hsils) to prevent anal cancer as developed in high-income settings will be conducted. investigators will identify barriers and facilitators with learning the procedure with standard training using the consolidated framework for implementation research (cfir). in aim 2, investigators will identify strategies to modify the standard training to improve learning on a complicated procedure using the expert recommendations for implementing change (eric) framework. an implementation science committee will co-design and develop an enhanced training on screening and treatment of hsil (e-sth) by matching the barriers identified with cfir with strategies in eric. investigators will then take an iterative improvement approach to test and refine the implementation of the enhanced training intervention to ensure that hsil screening and treatment is readily adopted and maintained as part of hiv care. in aim 3 (clinical trial aim), investigators will conduct a hybrid type 2 trial using an interrupted time series design to monitor and evaluate outcomes along the implementation continuum. the trial will be conducted at a single clinic to minimize variability. the participant (physician) will have a pre-period of hsil screening and treatment for 12 months after standard training. next, investigators will roll out e-sth for 6 months. then there will be a post-period of screening for 12 months to evaluate the impact of e-sth. lastly, there will be 6 months of screening and treatment with minimal involvement of the investigative team to evaluate sustainability. the study will compare e-sth to standard training in proportion of hsil detected and treated with secondary outcomes evaluating reach, efficacy, implementation, and sustainability.

Eligibility criteria:
inclusion criteria: 1. possess a medical degree in medical sciences (mbbs or equivalent) 2. at least 2-5 years of experience working with clinical hiv/aids community 3. must be registered with the medical and dental council of nigeria 4. possess a current medical practicing license 5. willing to work with the sexual gender minority community exclusion criteria:
autologous chondrocyte transplantation for articular cartilage regeneration

Conditions: Tear; Knee, Cartilage, Articular

Summary: the purpose of this study is to assess safety and efficacy of autologous chondrocyte implantation delivered arthroscopically into chondral lesions of the knee using clinical, biochemical, and mri outcomes.

injuries to the articular cartilage of the knee are common. they produce pain and deteriotation of patients' quality of life. the management of focal chondral lesions continues to be problematic for the treating orthopaedic surgeon. although many treatment options are currently available, none fulfill the criteria for an ideal repair solution: a hyaline repair tissue that completely fills the defect and integrates well with the surrounding normal cartilage. autologous chondrocyte implantation is a relatively new cell-based treatment method for full-thickness cartilage injuries that in recent years has increased in popularity, with different studies showing promising results. typically, this implantation is performed in an open-surgery fashion. in our study the implantation of in-house autologous chondrocyte culture is done arthroscopically, situation that may offer advantages in surgery associated morbidity and patient recovery.

Eligibility criteria:
inclusion criteria: * patients with symptomatic chondral lesions of the knee exclusion criteria: * inflammatory arthritis * septic arthritis * total meniscectomy * previous microfracture at chondral lesions * paget * ochronosis * acromegalia

Keywords: chondral lesions knee
nasal vs oral breathing in drug induced sleep vs natural sleep

Conditions: Sleep Apnea, Obstructive

Summary: this project will provide important new information regarding (1) the relationship between route of breathing and airway collapsibility and (2) whether route of breathing during dise (drug-induced sleep endoscopy) is representative of natural sleep.

as part of standard of care, a drug-induced sleep endoscopy will be done, where route of breathing will be determined as a percentage of total breaths (during baseline, lateral sleep and maneuver). as part of the research procedure, an in-laboratory polysomnogram will be conducted as study procedure including a oronasal pressure signal cannula to assess route of breathing.

Eligibility criteria:
inclusion criteria: * • adults (≥ 18yrs) that underwent clinical evaluation at the cpap alternatives clinic at penn otorhinolaryngology. * must have at least mild osa (ahi\>5) exclusion criteria: * • sleep study with an ahi\ 25% of total events being central or mixed events, or inability to achieve adequate drug-induced sleep. * upper respiratory illness at the time of the dise.

Keywords: breathing route osa nasal breathing oral breathing
metatarsophalangeal arthrodesis of the hallux

Conditions: Hallux Deformity

Summary: the purpose of the study is to describe the rate of bone fusion (radiological consolidation) in the 2 groups (a and b) 4 months after the operation.

the main objective of the study is to describe the rate of bone fusion obtained with the different types of osteosynthesis material: dorsal plate, large-diameter compression screw. patients will be divided into two groups: * patient undergoing arthrodesis of the hallux with a large diameter screw (group a) * patient undergoing arthrodesis of the hallux by plate (group b) this is a prospective, cross-sectional, open, comparative, non-randomized, non-interventional, monocentric study on two methods of synthesis (large-diameter plate or screw) of hallux metatarsophalangeal arthrodesis. patients will be managed in accordance with current practice, the choice of surgical strategy (percutaneous / open) being left to the discretion of the investigators.

Eligibility criteria:
inclusion criteria: * patient undergoing isolated first ray surgery (m1 only) of hallux valgus, hallux varus or hallux rigidus by percutaneous or conventional approach; * patient who can benefit from first-line arthrodesis using a dorsal plate or large-diameter screw; * patient able to understand information related to the study and complete quality of life questionnaires; * patient accepting study follow-up visits; * patient having been informed and agreeing to participate in the study. exclusion criteria: * pregnant or breastfeeding women; * patient undergoing lateral ray surgery; * patient undergoing revision arthrodesis; * patient with a loss of bone substance requiring a graft; * patient suffering from chronic inflammatory disease; * patient treated with long-term immunosuppressive or corticosteroid treatments; * patient under guardianship or curatorship, or under a regime of deprivation of liberty.
splint versus steroid randomized trial

Conditions: De Quervain Syndrome

Summary: the primary aim is to compare the effectiveness of splinting versus steroid injection in improving the dash scores in participants diagnosed with de quervain's tenosynovitis over a period of 6 months.

the primary hypothesis is that steroid injection into the first dorsal compartment is more effective compared with splinting at 3 months. the secondary hypothesis is that steroid injection yields better clinical outcomes compared with splinting at 1 month, 3 months and 6 months.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of de quervain's tenosynovitis based on the de quervain's screening tool (dqst) with scores ≥ 5 (refer to table 1) * no prior treatment * above 21 years of age exclusion criteria: * allergy to steroid (triamcinolone acetate) or local anaesthetic (lignocaine) * history of work related trauma
otx-15:003: a phase 3 study evaluating the safety and efficacy of otx-dp for the treatment of ocular inflammation and pain after cataract surgery

Conditions: Post-Surgical Ocular Pain; Post-Surgical Ocular Inflammation

Summary: the objective of the study was to evaluate the safety and efficacy of otx-dp (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular lens implantation


Eligibility criteria:
inclusion criteria: * has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of posterior chamber lens * has a potential post-operative pinhole corrected snellen va of at least 20/200 or better in both eyes exclusion criteria: * any intraocular inflammation in the study eye present during the screening slit lamp examination * score greater than "0" on the ocular pain assessment in the study eye at screening * any intraocular inflammation in the study eye present during the screening slit lamp examination
a comparison of techniques for treating skin abscesses

Conditions: Cutaneous Abscess

Summary: management of abscesses traditionally involves incision and drainage (i\&d). abscesses are frequently are "packed" or stented open with the presence of a wick, and traditional care requires re-visits every 2-3 days to have the packing removed and replaced, until finally the abscess cavity has closed, usually 1-2 weeks after initial presentation. recently there have been attempts to employ less invasive techniques for abscess management. one novel technique, "loop drainage", has been reported in case reports/case series for management of a variety of types of abscesses in the surgical subspecialty literature. we propose to conduct a randomized prospective study comparing the efficacy of the loop drainage technique with the traditional incision and drainage technique of abscess management. patients presenting to the main or urgent care areas of the emergency department at boston medical center for treatment of an abscess will be considered for enrollment as potential subjects. after the treating clinician identifies the patient as an appropriate subject, a research associate (ra) will approach the patient and obtain written informed consent to enroll in the study. the subject will then be randomized to the management arm of either loop drainage or traditional i\&d. the clinician will fill out a data sheet describing the abscess characteristics, and then perform either loop drainage or incision and drainage, depending on randomization and the subject will fill out a satisfaction survey. fourteen days after initial visit, subjects will return for follow-up. the subject will fill out a satisfaction survey, and a study investigator blinded to the treatment group will assess the subject for abscess resolution, cosmetic outcome, number of follow-up visits, and complications. the study investigators will then compare outcomes between the two study groups.


Eligibility criteria:
inclusion criteria: * adult patient over 18 years of age * presenting to the boston medical center main emergency department or urgent care area for initial treatment of a skin abscess * english speaking * able to provide written informed consent * willing to return in 14 days for follow-up visit * able to give a telephone number for follow-up contact exclusion criteria: * previously treated for this abscess * altered mental status * patients with active psychiatric issues that preclude their ability to provide informed consent * previously enrolled in the study * abscess is not amenable to treatment by an emergency physician in the emergency department * abscess is post-operative or post-procedure * clinician determines abscess is not amenable to drainage by particular method * abscess is too small for packing or loop * need for hospital admission

Keywords: cutaneous abscess emergency department
standard diagnostic procedures with or without fludeoxyglucose f 18 positron emission tomography in finding cancer in patients with a blood clot in a vein

Conditions: Thromboembolism; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: diagnostic procedures, such as fludeoxyglucose f 18 positron emission tomography, may help find and diagnose cancer. it is not yet known whether standard diagnostic procedures are more effective when given with or without fludeoxyglucose f 18 positron emission tomography in finding cancer. purpose: this randomized clinical trial is studying fludeoxyglucose f 18 positron emission tomography given together with standard diagnostic procedures to see how well it works compared with standard diagnostic procedures alone in finding cancer in patients with a blood clot in a vein.

objectives: primary * demonstrate the efficacy, in terms of increased numbers of cancer diagnoses, of pet-ct with 18-fdg in patients with idiopathic venous thromboembolism. secondary * assess the risk of cancer detected at 1 year. * assess whether pet allows earlier detection of cancer. * evaluate survival. outline: this is a multicenter study. all patients undergo standard (clinical and biological) diagnostic tests for cancer. patients are randomized to 1 of 2 diagnostic arms. * arm i: patients undergo diagnostic fludeoxyglucose f 18 pet in addition to standard methods. * arm ii: patients only undergo standard diagnostic methods. patients are followed up for 2 years.

Eligibility criteria:
disease characteristics: * diagnosis of idiopathic venous thromboembolism (ivte) meeting 1 of the following criteria: * newly diagnosed * recurrent disease controlled by anticoagulant therapy * no ivte caused by a reversible major risk factor * no ivte caused by a major constitutional risk factor, including any of the following: * antiphospholipid antibody syndrome * antithrombin deficit * protein c * protein s patient characteristics: * not pregnant * no other known active cancer at the onset of ivte

Keywords: unspecified adult solid tumor, protocol specific thromboembolism
multisensory rehabilitation of hemianopia

Conditions: Hemianopia

Summary: the current proposal is to generate "proof of concept" evidence that hemianopia can be successfully rehabilitated in humans when this multisensory rehabilitation paradigm is used.

the over-arching objective is to evaluate the functional recovery of vision in hemianopic patients engaged with a multisensory training paradigm. unilaterally blind participants will participate in weekly training sessions in which they are exposed to high-density spatiotemporally congruent and consistent visual-auditory stimulation. the participants will be tested on a battery of visual tasks probing different levels of function in different environments in a longitudinal study to track recovery.

Eligibility criteria:
inclusion criteria: * adults (\<85) of either sex * diagnosis of a stable homonymous hemianopia (\>6 months) with absence of hemineglect * lesion encompassing at least primary visual cortex but sparing parietal cortex * normal auditory and cognitive function * willingness to participate in the three month program * ability to perform the visual discriminations in their intact field exclusion criteria: * adults (\>85) * normal auditory and cognitive function * unwilling to participate in the three month program * inability to perform the visual discriminations in their intact field

Keywords: visual cortex injury stroke blindness cortical damage